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The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The following indications are for the S and SL type anchors only:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Hip: Capsular repair, Acetabular Labral repair

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver.

B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair.

Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type.

SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas.

S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist

The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone.

Devices are provided sterile. Single use only.

The provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) submission to the FDA. This submission aims to demonstrate substantial equivalence to previously cleared devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document discusses:

• Device Description: What the Fixone Biocomposite Anchor is, its components (PLGA copolymer and β-TCP anchor, UHMWPE suture), and how it's implanted.
• Intended Use: Fixation of suture (soft tissue) to bone in various anatomical locations (shoulder, foot/ankle, knee, elbow, hand/wrist, hip).
• Predicate Device Comparison: A detailed table comparing the subject device to several predicate devices (K171299, K192032, K192484, K213008) across various attributes like indications for use, materials, dimensions, fixation mechanism, suture characteristics, and sterilization.
• Performance Data: Mentions "Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues, shelf-life testing, pyrogenicity testing and endotoxin monitoring. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices."

Crucially, there is no mention of:

• AI/ML components: The device is a physical biocomposite anchor, not a software algorithm.
• Clinical study or diagnostic performance metrics: The performance data refers to bench testing for physical and material properties, not clinical outcomes, sensitivity, specificity, or AUC for a diagnostic tool.
• Ground truth, expert readers, sample sizes for AI models, or MRMC studies. These are concepts relevant to evaluating AI/ML diagnostic or predictive devices, which the Fixone Biocomposite Anchor is not.

Therefore, I cannot fulfill the request as the provided input does not contain the necessary information about acceptance criteria and a study proving an AI/ML device's performance. The device described is a traditional medical implant, and its evaluation focuses on physical and biological equivalence, not AI performance.

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The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, BLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot. ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In con junction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.

The OneFix Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The OneFix Cannula System is introduction of instrumentation through a portal for surgical procedure.

The OneFix Biocomposite Anchors consist of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 96 model codes over 4 families. The anchors widths range from 3.0mm through 6.5mm and lengths of 11.9mm through 16.8mm.

The OneFix Biocomposite Small Anchors consist of cannulated anchors with an eyelet. They are preloaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 9 model codes corresponding to variations of sutures with anchor dimensions (11.9mm x 2.4mm x 3.0mm).

The OneFix All Suture Anchors consist of one "fixed suture" and 2 or 3 non-absorbable sutures. The non-absorbable suture is manufactured from UHMWPE and PET fibers. The OneFix All Suture Anchor is implanted using its self-punching option and are pre-loaded on a handled insertion device. They come in 14 various model codes.

The OneFix Biocomposite Interference Screws are inserted into the bone tissue and the external thread is screw shaped and the inside of the screw is start shaped. The screws are manufactured from PLGA copolymer and ß-TCP. There are 36 model codes with outside diameter ranging from 7-12mm and 20-35mm lengths.

The OneFix Cannula Systems is intended to puncture through tissue to make a pathway for surgical instruments during surgery. It consists of a cannula and a trocar made of polycarbonate. There are 3 types of this product: threaded, smooth and all smooth and comes in 72 model codes with inside diameter of 4.3mm through 8.1mm and lengths of 84mm through 130mm.

All implant components are provided sterile and are designated as single use. The system also includes the reusable surgical instruments required for implantation.

The provided document is a 510(k) summary for medical devices, specifically orthopedic bone fixation appliances. It does not contain information about acceptance criteria for a study, nor does it describe a study that proves a device meets acceptance criteria in the way typically associated with AI/ML-driven devices (e.g., performance metrics like sensitivity, specificity, or reader studies).

This document is for a traditional medical device (anchors, screws, and cannulas) used in orthopedic surgery. The "study" referenced here is the comparison to predicate devices to demonstrate substantial equivalence, which is a regulatory pathway for market clearance for certain types of medical devices.

Therefore, many of the requested categories in your prompt are not applicable to the content of this FDA 510(k) summary for a physical orthopedic device.

Here's an explanation based on the provided text and why certain sections of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical trial or algorithm test for a new technology like AI/ML. The "performance" described is in terms of material properties, design features, and intended use being similar to predicates.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. There is no "test set" in the context of an AI/ML algorithm or clinical study described. The "test" in a 510(k) often refers to bench testing (e.g., mechanical strength) which is not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable / Not provided. No ground truth establishment for a diagnostic or prognostic task is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not provided. This device is a physical surgical implant/tool, not an AI-based diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. The device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable / Not provided. There is no "training set."

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in a 510(k) context for a traditional device largely revolve around demonstrating substantial equivalence to predicate devices. This is achieved by comparing technological characteristics, intended use, and materials.

The "study" or evidence provided to meet this "acceptance criteria" (substantial equivalence) is a qualitative comparison of the new device (OneFix product line) to several predicate devices.

Comparison of Technological Characteristics (as described in the document):

The document explicitly states:
"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems and the predicate devices share the following characteristics:

• Materials of construction
• Manufacturing processes
• Sizes offered
• Product design for shape and macrostructures
• Sterilization methods"

Predicate Devices Used for Comparison:

The devices for which substantial equivalence is claimed are:

• Fixone Biocomposite Anchors; K192484
• Fixone Biocomposite Small Anchors; K192032
• Fixone All Suture Anchors; K192709
• Fixone Interference Screws; K193497
• JOINIX Cannula System; K162070

In conclusion, this document demonstrates that the OneFix product line is substantially equivalent to already cleared predicate devices based on a comparison of their intended use, technological characteristics (materials, manufacturing, size, design, sterilization), and performance (implied to be similar because of the equivalence in characteristics and materials). No specific quantitative performance metrics or studies in the context of AI/ML are presented.

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The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The furnished document is an FDA 510(k) Premarket Notification for the medical device "Fix2Lock". This document is a clearance letter, not a study report for an AI/ML medical device. It pertains to a bone fixation screw and its substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive technology.

Therefore, the document does not contain the information requested in the prompt regarding:

• Acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Types of ground truth.
• How ground truth for training data was established.

The document discusses non-clinical bench tests to verify the subject device's design specifications and compliance with various ASTM and ISO standards for materials, mechanical performance, sterilization, and packaging. This is for a physical implantable device, not a software algorithm.

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